Chief Medical Officer

Permanent Opportunity

168k+ Competitive Bonus +Stock Package (negotiable)

Montpellier/Remote 

Chief Medical Officer

We are looking for a hands-on Chief Medical Officer (CMO) to join our Montpellier, France facility to participate in our on-going success as a financially sound, fast-growing, socially responsible company dedicated to Global Health.

As the CMO, you will be responsible for the strategy, direction and execution of the company’s clinical development plans and activities (e.g., NDA/CTA submissions, study protocols, Investigator Brochures, regulatory briefing books and regulatory response documents, clinical study reports, etc.).  You will maintain key relationships with the company’s Development Team, contributing to the preparation of robust development plans, including providing content for clinical development and other sections, as needed.  Your role has responsibility for the in-house clinical development team as well as for outside vendor relationships (CROs, clinical consultants, statisticians).

On a broader level, you will support the management team with medical expertise and contribute to the development of overall corporate strategies.  You will represent the Company as its medical expert with external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners.      

Responsibilities 

Clinical Strategy

• Define strategic clinical development plans in close alignment with the Product Development Teams, Regulatory Affairs, and Non-Clinical Development  
• Present business cases, defend and get endorsement of the clinical strategic plan with the appropriate governance committees of the company (Development Committee, Strategic Investment Committee) 
• Support the different functions within the Clinical Team with his/her expertise and leadership (monitoring, data management, biostatistics, medical writing, pharmacovigilance)
• Ensure that the operational Clinical Development process is aligned with the company Standard Operation Procedures (SOPs) and help to improve current SOPs 
• Ensure the pharmacovigilance process of safety surveillance during clinical development and design the safety risk management plan 
• Build and maintain a strong network of internal and external collaborators, opinion leaders, investigators and competent authorities 
• Support continuous improvement activities, to develop our position as a center of Clinical Excellence for MedinCell and external partners 

Clinical Management

• Manage the clinical development process from early stage development until product approval and provide clinical leadership to support the clinical development, filing, approval and commercialization of the new products 
• Develop and put in place best-in-class clinical practices and team (internal team and external partners)
• Incorporate expert advice, clinical and commercial considerations, and strategic business needs into the design and implementation of clinical development plans
• Define and implement clinical development projects including objectives, work plans, milestones and deliverables

• Represent MedinCell in the design, oversight and execution of early stage and pivotal clinical trials in line with Good Clinical Practice (GCP)
• As required, participate in selecting clinical CROs, developing budgets, validating the study implementation plans
• Contribute to and oversee protocol development from concept to final protocol
• Ensure studies are managed and executed in compliance with GCP/ICH guidelines, regulations, and company SOPs
• As required, interact with investigators, and lead data review, data analysis and clinical study report authoring
• Provide scientific interpretation of data from clinical studies
• Actively support the regulatory submission process
• Lead the preparation and submision of the clinical sections of regulatory document submissions and responses (IND/IMPD, BLA/NDA/MAA) in close collaboration with the Regulatory Affairs team
• Lead the preparation of key clinical documents to be prepared for clinical trials (protocols, reports), CTD submissions, interactions with governance bodies, external clinical and medical experts and committees. 
• Prepare for and represent MedinCell in front of FDA, EMA or other regulatory bodies for clinical development topics

Medical Expertise

• Serve as a cross-functional leader and subject matter expert on all clinical and medical strategic initiatives
• Develop deep clinical expertise and knowledge of our product portfolio
• Participate in Strategic Investment Review meetings providing medical and clinical development expertise and plans
• Provide medical/scientific input to evaluate potential business opportunities
• Expand and optimize the labeling of company products in alignment with strategic priorities through smart, targeted and cost-effective clinical research

• Foster scientific exchange and raise the scientific profile of MedinCell
• Serve as the primary contact person for MedinCell’s Medical Advisory Board
• Develop trust-based relationships with highly respected scientists, physicians, renown principal investigators, etc.
• Present at academic congresses, investigator meetings and advisory meetings

People Management

• Recruit best talents for the Clinical Development team
• Manage people working in the Clinical Development team and secure smooth relationships across the organization to ensure efficacy
• Build, mentor, empower and develop a highly skilled team of professionals and instill high performance standards

Requirements

• Medical Doctor (MD)
• Minimum fifteen (15) years of experience in clinical development in pharmaceutical

Industry; relevant experience in CNS or pain management is a plus

• Strong hands-on experience in all clinical development phases through regulatory approval and life-cycle management
• Experience with regulatory activities in US and EU
• Experience in working in development partnerships such as co-development agreements
• Expert knowledge of drug development processes and regulations
• Clinical experience specifically in injectables; experience in drug delivery systems (DDS) is a plus

Get in touch for an informal discussion at enza.demarco@medincell.com